Director Regulatory Affairs Strategy

Historically, the travel requirement for this position has ranged from 80-100%. The safety and well-being of our people continues to be the top priority, and our decisions around travel are informed by government COVID-19 response directives, recommendations from leading health authorities, and guidance from a number of infectious disease experts. For now, all KPMG business travel, international and domestic, is currently restricted to client-essential sales/delivery activity only. At some point in the future and with the safety of people as the critical factor, the travel requirement will likely increase, possibly to previous levels, but KPMG is committed to balancing client requirements with new delivery capabilities.

The KPMG Advisory practice is currently our fastest growing practice. We are seeing tremendous client demand, and looking forward we don't anticipate that slowing down. In this ever-changing market environment, our professionals must be adaptable and thrive in a collaborative, team-driven culture. At KPMG, our people are our number one priority. With a wealth of learning and career development opportunities, a world-class training facility and leading market tools, we make sure our people continue to grow both professionally and personally. If you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory.

KPMG is currently seeking a Director Regulatory Affairs Strategy in Customer & Operations for our Consulting practice.

Responsibilities:

• Deliver advisory services to Pharmaceutical and Life Sciences clients, primarily to the Regulatory Affairs function
• Advise clients throughout the product development pathway from early phase development and clinical trials to marketing authorization and maintaining compliance for approved products in global markets
• Support Regulatory Affairs services with an emphasis on regulatory strategy and activities that enable preparation, review and submission of documents to health authorities globally
• Provide consultation on regulatory requirements to support regulatory submissions to health authorities in different global jurisdictions
• Assist teams responsible for the technical review, authoring or assembly of Clinical, Pre-Clinical or CMC dossiers, for example preparation and maintenance of IND, CTA, NDA, BLA, MAAs or scientific advice procedures with global health authorities
• Engage with clients on the impact of the changing pharmaceutical regulatory landscape on their business models and support them through change

Additional Responsibilities:

• Manage client engagements, including facilitating engagement decisions, work plan, timeline and project management
• Lead business development activities in the Life Sciences industry such as client identification, proposal development, and creation of marketing collateral

Qualifications:

• Minimum eight years of recent consulting or business experience or combination thereof in the Life Sciences industry
• Bachelor's degree from an accredited college/university; Master's degree from an accredited college/university and prior management consulting experience preferred
• Significant experience working in or consulting with Regulatory Affairs functions within Pharmaceutical and Life Sciences companies; strong experience interacting with major health authorities including FDA and EMA
• Understanding of pharmaceutical regulations and an ability to identify and interpret legislation, guidelines, and relevant information published by global health authorities; relevant certifications preferred such as Regulatory Affairs Certification (RAC); excellent foundational skills including strong analytical, written and verbal communication skills, MS Office expertise, impactful client presence, compelling facilitation and presentation skills
• Ability to travel as needed
• Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future

KPMG LLP (the U.S. member firm of KPMG International) offers a comprehensive compensation and benefits package. KPMG is an affirmative action-equal opportunity employer. KPMG complies with all applicable federal, state and local laws regarding recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by applicable federal, state or local laws. The attached link contains further information regarding the firm's compliance with federal, state and local recruitment and hiring laws. No phone calls or agencies please.

KPMG does not currently require partners or employees to be fully vaccinated or test negative for COVID-19 in order to go to KPMG offices, client sites or KPMG events, except when mandated by federal, state or local law.  In some circumstances, clients also may require proof of vaccination or testing (e.g., to go to the client site).       /